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Latex Leg Bag-57.XX

by Manfred Sauer Corp.

510(k) K812252

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812252 Date20 Aug 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KNX
Device Class
Class II
Regulation
21 CFR Part 876.5250
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Latex Leg Bag 57.XX is a collector for urine and accessories for indwelling catheters. It is designed to collect urine drainage from a catheter, sheath, or urostomy.

This device is authorized under FDA 510(k) clearance K812252. It is supplied by Manfred Sauer Corp. and is intended for use in urology and gastroenterology settings.

Other devices from Manfred Sauer Corp.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Latex Leg Bag 57.XX?

    This device is designed to collect urine drainage from patients using indwelling catheters, sheaths, or urostomies. It serves as a collection reservoir for urology and gastroenterology applications.

  • In what clinical settings is this device intended to be used?

    The Latex Leg Bag 57.XX is intended for use within urology and gastroenterology clinical settings to manage urine drainage.

  • Is this device authorized for use?

    Yes, the Latex Leg Bag 57.XX is authorized under FDA 510(k) clearance K812252, which indicates it has been found substantially equivalent to other legally marketed devices.